When medical devices, such as orthopedic implants, are removed from patients (“explanted devices”), they must frequently be shipped to a third party for examination and/or analysis for a variety of reasons, including regulatory responses and determination of liability in civil court actions. These materials are potentially biohazardous to those individuals handling the items during retrieval, shipping and examination.
In the past, medical personnel responsible for returning explanted orthopedic devices had to package, label, and ship the items by using packaging and labels chosen at their own discretion, which were often less than adequate. Many packages were packed and labeled in a manner lacking protection for those handling the package from potentially contaminated material.
Several patents describe methods and devices for preserving and transporting biological materials or prosthetic devices. U.S. Pat. No. 3,255,871 to Butler is directed to the use of a translucent plastic bag in which a formaldehyde solution is formed in situ for preserving and transporting biological material. U.S. Pat. No. 4,011,947 to Sawyer describes a packaged prosthetic device and a packaging technique designed so that a prosthetic device will arrive at its ultimate position for installation in a sterile and clean condition.
U.S. Pat. No. 5,236,088 to Dhority et al. is directed to an orthopedic implant retrieval kit which, when assembled, provides a shipping and handling container for explanted orthopedic devices. The kit includes a container for holding a suitable level of formalin solution. The container is sealed within several other containers to prevent leakage. The multiple containers have absorbent material positioned thereabout to also prevent leakage.
There is a need to provide a retrieval kit in which tissue can be shipped in a secure, safe and non-degenerative manner across long distances and international boundaries. There is also a need to provide a retrieval kit in which the issue of leakage is essentially eliminated, thereby allowing the retrieval kit to be easily assembled and easily and securely shipped.